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Tertiary Prevention of Head and Neck Cancer With a Dietary Intervention

NCT02869399 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2023-03-13

No results posted yet for this study

Summary

This is an open-label randomized phase II multicenter trial. An estimated 350 patients deemed to be in complete remission at month 3 after curative treatment are considered for this trial. Two arms of intervention are foreseen: the experimental arm (arm A) based on dietary intervention in addition to standard recommendations and a control arm (arm B) including only standard recommendations. The intervention strategy is based on the AICR/WCRF recommendations for cancer and recurrences prevention and it is focused on decreasing inflammation, glycaemia and insulinaemia while promoting nutrient-rich diet. The reduction in the incidence of tumor recurrence will be analyzed comparing EFS curves between the two arms with the non-parametric Kaplan-Meier method. Secondary analyses will describe the time trend in the prevalence of side effects and quality of life, as assessed by the EORTC QLQ-H\&N35 questionnaire. Translational analysis (cytokine, salivary and plasmatic miRNA) will be performed. The trial is coordinated by Istituto Nazionale Tumori, Milan and conducted in 6 European countries.

Conditions

  • Cancer of Head and Neck

Interventions

DIETARY_SUPPLEMENT

dietary intervention in addition to standard recommendations

The diet of the intervention group will be based on the AICR/WCRF recommendations for cancer prevention and for the prevention of recurrences (www.dietandcancerreport.org): * avoid or limit alcoholic drinks (2 drinks men, 1 drink women) * increase consumption of a variety of non-starchy vegetables, fruits (at least 400g per day) and dietary fibers (at least 25g per day) * eat mostly food of plant origin * eat lean meat, limit intake of red meat and avoid processed meat * increase consumption of anti-inflammatory foods, such as fish and whole grain cereals, f.e. brown rice and barley creams * avoid high glycaemic and high insulinemic foods, such as refined flours, white breads, and pastries

Sponsors & Collaborators

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Principal Investigators

  • Lisa Licitra, MD · Fondazione IRCCS Istituto Tumori Milano

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-11-30
Completion
2023-02-28

Countries

  • Austria
  • Germany
  • Italy
  • Poland
  • Portugal
  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02869399 on ClinicalTrials.gov